NCT01867164

A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis

A Prospective, Open-Label, Comparative, Parallel Double-Arm, Multicentric Clinical Study to Evaluate the Efficacy of an Ovule With Triple Active Agents (Terconazole, Clindamycin, Fluocinolone) Administered Once Per Day for Three Days Versus an Ovule With Triple Active Agents (Metronidazole, Nystatin, Fluocinolone) Administered Once Per Day for Ten Days to Treat Secondary Vulvar/Vaginal Symptoms of Vaginitis/Infectious Vaginosis (Bacterial and/or Mycotic and/or Parasitic)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Janssen-Cilag, S.A. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this comparative study is to evaluate the efficacy of an ovule with triple active agents (terconazole, clindamycin and fluocinolone) versus another ovule with triple active agents (nystatin, metronidazole and fluocinolone) in the treatment of symptoms caused by the presence of vaginitis (inflammation of the vagina) or bacterial vaginosis (polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella vaginalis and other anaerobic organisms and a decrease in lactobacilli).

Detailed description

This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), comparative, parallel (a clinical trial comparing the response in 2 or more groups of participants receiving different treatments) double-arm, multi-center (when more than 1 hospital or medical school team work on a medical research study) study. The study consists of 3 phases: Screening phase on Visit 1 (Day -3/1); Inclusion or treatment phase on Visit 2 (Day 1); and Treatment or monitoring phase (3 days after treatment) on Visit 3 (Day 7 for Gynoclin V and Day 13 for Vagitrol V) and Visit 4 (Day 12 for Gynoclin V and Day 18 for Vagitrol V). Participants will be randomly assigned to 1 of the 2 treatment groups: Gynoclin V and Vagitrol V. Participants in Gynoclin V group will be administered 1 ovule (containing 80 milligram \[mg\] terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide) vaginally every 24 hours at night, for 3 days. Participants in the Vagitrol V group will be administered 1 ovule (containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin) vaginally every 24 hours at night, for 10 days. Primarily, participants will be evaluated for signs and symptoms, characteristics of vaginal discharge, changes in vulvar region, changes in cervix and presence of bacteria, fungi and/or parasites. Participants' safety will be monitored throughout the study.

Conditions

• Vaginitis
• Infectious Vaginosis

Interventions

Type	Name	Description
DRUG	Gynoclin V	One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide will be administered vaginally, every 24 hours at night, for 3 days.
DRUG	Vagitrol V	One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin will be administered vaginally, every 24 hours at night, for 10 days.

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2013-06-03
• Last updated: 2013-12-24
• Results posted: 2013-12-24

Locations

2 sites across 1 country: Mexico